Document: Buprenorphine Bluefish sublingual tablet ENG PL change

• Buprenorphine Bluefish sublingual tablet PL
• Buprenorphine Bluefish sublingual tablet ENG PL

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Package leaflet: Information for the user

Buprenorphine Bluefish 0.4, sublingual tablets

Buprenorphine Bluefish 2 mg sublingual tablets

Buprenorphine Bluefish 8 mg sublingual tablets

buprenorphine

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.

• If you have any further questions, ask your doctor or pharmacist or nurse.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• If you get any of the side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet, See section 4.

In this leaflet:

1. What Buprenorphine Bluefish is and what it is used for

2. What you need to know before you take Buprenorphine Bluefish

3. How to take Buprenorphine Bluefish

4. Possible side effects

6. Contents of the pack and other information.

Buprenorphine Bluefish is used:

The treatment is prescribed and monitored by doctors specialized in treating drug addiction.

Do not take Buprenorphine Bluefish if you

• If you are allergic to buprenorphine or any of the other ingredients of this medicine (listed in section 6).

• suffer from serious breathing difficulties

• suffer from a seriously reduced liver function

• suffer from alcoholism or delirium tremens.

Warnings and precautions

Talk to your doctor or pharmacist or nurse before taking Buprenorphine Bluefish if you:

• have taken morphine or heroin (opioids)less than 6 hours ago, as withdrawal symptoms can occur

• have taken methadone less than 24 hours ago, as withdrawal symptoms can occur (if you use methadone your dose may have to be adjusted before you take buprenorphine, see section 3)

• suffer from asthma or breathing difficulties

• suffer from reduced function of the kidneys or the liver. If you suffer from serious liver insufficiency, you must not take buprenorphine

• suffer from low blood pressure

• have difficulty passing urine (because of an enlarged prostate gland or urethral stricture)

• suffer from a head injury and have an increased intracranial pressure

Misuse, abuse and diversion

Serious cases of infections with potential fatal outcome may occur in context of misuse of Buprenorphine Bluefish, when taken by intravenous route.

This medicine can be a target for people who abuse prescription medicines, and should be kept in a safe place to protect it from theft. Do not give this medicine to anyone else. It can cause death or otherwise harm them.

Observe that Buprenorphine Bluefish may:

• cause dependence

• cause your blood pressure to drop suddenly, causing you to feel dizzy and unwell if you get up too quickly from sitting or lying down

• mask other diseases where pain is a symptom since buprenorphine has a pain relieving effect.

Other medicines and Buprenorphine Bluefish

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

Buprenorphine may influence the effect of other medicines and other medicines may influence the effect of buprenorphine.

It is therefore important you tell your doctor if you use any of the following medicines:

• medicine used in the treatment of anxiety and disquiet and sleeping difficulties (benzodiazepines and anxiolytics other than benzodiazepines)

• medicine used in the treatment of skin infection in the scalp (ketoconazole, itraconazole)

• medicine used in the treatment of certain infections (rifampicin)

• medicine used in the treatment of HIV (ritonavir, indinavir, nelfinavir)

• some types of medicine used in the treatment of allergy

• some types of medicine used in the treatment of depression

• medicine used in the treatment of migraine, hot flushes and abstinences as a result of medicine abuse (clonidine)

• cough medicine (dextromethorphan, noscapine)

• painkillers (morphine and morphine-like substances)

• medicine containing alcohol

• medicine used in the treatment of epilepsy (phenobarbital, phenytoin, carbamazepine)

• medicine used in the treatment of psychosis (neuroleptics)

• medicine used as sedatives and to relieve convulsions (barbiturates).

Buprenorphine Bluefish with food, drink and alcohol

You can take Buprenorphine Bluefish independently of a meal.

Do not drink alcohol when you are treated with Buprenorphine Bluefish since alcohol will increase the sedative effect of buprenorphine.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby,

ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

You should not use buprenorphine during your pregnancy. But if your doctor finds it appropriate an exception can be made for the first 3 months of your pregnancy.

Breast-feeding

Do not take buprenorphine if you are breast-feeding.

Driving and using machines

Buprenorphine Bluefish can be sedating, cause fainting and dizziness, and therefore it can reduce the ability to drive and use machines.

Do not drive or use machines if you feel dizzy or drowsy. This usually occurs at the beginning of treatment and when the dose is increased.

Buprenorphine Bluefish contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product

Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

This is the way you take Buprenorphine Bluefish

A sublingual tablet is a tablet that is taken under your tongue. Keep the tablet dose under your tongue until it dissolves – normally it takes 5-10 minutes. Do not swallow, crush or chew the tablet.

Usual dose if you are/have:

Your initial dose will be between 0.8 to 4 mg (one tablet once daily). Your doctor will increase your dose according to your response to the treatment until you have a stabile dose, 16 mg daily is often sufficient. The maximum daily dose is 24 mg. Your doctor will then individually determine the length of your treatment and gradually reduce your dose. Do not change the treatment in any way or stop treatment without the agreement of the doctor who is treating you.

Children and adolescents under the age of 18 must not use Buprenorphine Bluefish.

If you have problems with your kidneys or liver your dose may have to be reduced. Talk to your doctor. If you suffer from serious liver insufficiency, you must not take buprenorphine.

Your dose of methadone has to be reduced to a maximum of 30 mg daily before starting treatment with Buprenorphine Bluefish. Contact your doctor if you experience withdrawal symptoms (sweating, disquiet or restlessness).

If you take more Buprenorphine Bluefish than you should

In case of overdose of buprenorphine, you must go or be taken immediately to an emergency centre or hospital for treatment.

Symptoms of an overdose is breathing difficulties, slowly breathing or heart symptoms.

Toxic poisoning has been observed after misuse (overdose or wrong administration) and in worst case it can result in stop of breathing/heart failure and/or liver damage.

If you forget to take Buprenorphine Bluefish

Do not take a double dose to make up for a forgotten dose.

If you stop taking Buprenorphine Bluefish

Do not stop the treatment yourself, but ask your doctor how to end the treatment.

A sudden interruption can cause withdrawal symptoms (sweating, disquiet and restlessness).

If you have any further questions on the use of thismedicine, ask your doctor or pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

You should stop taking Buprenorphine Bluefish and see your doctor immediately if you experience symptoms of angioneurotic oedema, such as:

• swollen face, tongue or pharynx

• difficulty to swallow

• hives and difficulties to breath

Addiction to Buprenorphine Bluefish

Common side effects (may affect up to 1 in 10 people):

• Headache

• fainting

• dizziness

• obstipation

• nausea,

• vomiting

• insomnia

• drowsiness

• feeling of weakness

• drop in blood pressure on changing position from sitting or lying down to standing

• sweating.

In long term use of buprenorphine, the common undesirable effects diminish successively. However, constipation and sweating often remain.

Rare side effects (may affect up to 1 in 1,000 people):

• Hallucinations

• respiratory depression

• bronchial spasm

• damage of the liver

• hepatitis

• anaphylactic shock

• angioneurotic oedema

• urine retention.

Reportingof side effects

If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Buprenorphine Bluefish

Keep this medicine out of the sightand reach of children.

Do not use this medicine after the expiry date which is stated on the label, blister and carton after EXP. The expiry date refers to the last day of that month.

Does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to through away medicines no longeruse. These measures will help protect the environment.

6. Contents of the pack and other information

What Buprenorphine Bluefish contains

• The active substance is buprenorphine as buprenorphine hydrochloride. Each sublingual tablet contains 0.4 mg, 2 mg and 8 mg buprenorphine respectively.

• The other ingredients are lactose monohydrate, mannitol (E421), maize starch, citric acid (E330), sodium citrate (E331), povidone (E1201), magnesium stearate (E470b).

• The 0.4 mg sublingual tablets also contain: Talc (E553b) and colloidal anhydrous silica.

What Buprenorphine Bluefish looks like and contents of the pack

Buprenorphine Bluefish 0.4 mg is a round, biconvex and white sublingual tablet.

Buprenorphine Bluefish 2 mg is an oval, biconvex and white sublingual tablet with “2” embossed on one side.

Buprenorphine Bluefish 8 mg is an oval, biconvex and white sublingual tablet with “8” embossed on one side.

Buprenorphine Bluefish is packed in blister packs of 7, 14 and 28 sublingual tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Bluefish Pharmaceuticals AB

P.O. Box 49013

100 28 Stockholm

Sweden

Manufacturer

Laboratórios Atral, S.A.,

Rua da Estação n°. 42,

Vala do Carregado,

Castanheira do Ribatejo, 2600-726

Portugal

This medicinal product is authorised in the Member States of the EEA under the following names:

SE (RMS) Buprenorphine Bluefish sublinguala resoribletter

DK Buprenorphine Bluefish sublinguale resoribletter

This leaflet was last revised in 2016-11-07